Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)

The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: DU-176b (edoxaban); Drug: Enoxaparin sodium 20mg

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Exclusion Criteria:

• Subjects with risks of hemorrhage
• Subjects with thrombolic risks
• Subjects who weigh less than 40 kg
• Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DU-176b; DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery	Drug: DU-176b (edoxaban)
Active Comparator: Enoxaparin sodium; Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery	Drug: Enoxaparin sodium 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Incidence of Major or Clinically Relevant Non-major Bleeding	Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of Subjects With Venous Thromboembolism Events.	2 weeks

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.
• Investigators: Principal Investigator: Takeshi Fuji, Osaka Kouseinennkin Hospital

Publications and helpful links

General Publications

• Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Kiuchi Y, Abe K, Tachibana S. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res. 2014 Jun;133(6):1016-22. doi: 10.1016/j.thromres.2014.03.009. Epub 2014 Mar 6.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: August 12, 2010
• First Submitted That Met QC Criteria: August 12, 2010
• First Posted (Estimate): August 13, 2010

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: thromboembolism; Thrombosis; embolism; hip fracture surgery; deep vein thrombosis; Anticoagulants; factor Xa; Edoxaban; Enoxaparin sodium; venous thromboembolism.; DU-176b
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Fractures, Bone; Wounds and Injuries; Leg Injuries; Embolism and Thrombosis; Femoral Fractures; Hip Injuries; Hip Fractures; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: DU176b-B-J303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR